MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION; INTESTINAL STIMULATOR

Model Number NEU_INS_STIMULATOR

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 10/06/2015

Event Type  Death  

Manufacturer Narrative

It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Concomitant product: product id neu_ins_stimulator, lot # unknown, product type implantable neurostimulator; product id neu_unknown_lead, lot # unknown, product type lead; product id neu_unknown_lead, lot # unknown, product type lead; product id neu_ins_stimulator, lot # unknown, product type implantable neurostimulator; product id neu_unknown_lead, lot # unknown, product type lead; product id neu_unknown_lead, lot # unknown, product type lead; product id neu_ins_stimulator, lot # unknown, product type implantable neurostimulator; product id neu_ins_stimulator, lot # unknown, product type implantable neurostimulator; product id neu_ins_stimulator, lot # unknown, product type implantable neurostimulator.(b)(4).

Event Description

Islam ,s., mclaughlin, j., pierson, j., jolley, c., kedar, a., abell, t.Long-term outcomes of gastric electrical stimulation in children with gastroparesis.Summary: gastric electrical stimulation (ges) has been used in adults with gastroparesis.However, its use has been limited in children.We describe the largest experience with ges in children with long-term outcomes.This study represents the largest experience of systematic application of ges in children.Ges is a safe and effective therapy for selected children with intractable gp with continued symptomatic improvement at 1 year and beyond.Reported events: information provided suggests 1 patient died after having the device explanted.A patient with gastric electrical stimulation (ges) for gastroparesis developed an infected seroma which was drained without recurrence.Two patients with ges for gastroparesis had a recurrence of symptoms within the first month of implant.In both cases it was noted that they were able to reposition the leads and improve the response.A patient with ges for gastroparesis did not have an immediate therapeutic response with the permanent implant, but reportedly had symptomatic relief after the lead position was changed.Five patients with ges for gastroparesis experienced a ¿failure of stimulation¿ between 4-18 months after implant, resulting in device explant.Three patients with ges for gastroparesis experienced but were able to regain an improvement in symptoms with lead repositioning.Two patients with ges for gastroparesis had the lead erode through the gastric mucosa and required reoperation with good success.A patient with ges for gastroparesis experienced traumatic disruption of the pocket, requiring device removal.An unknown number of patients with ges for gastroparesis who also had greater than 12 months of follow-up experienced a mean of 1 hospitalization compared to 3.6 at the pre-ges baseline.The mean length of stay was reportedly 13.5 days in this group, compared to the 10.7 at baseline.Further information has been requested; a supplemental report will be submitted if additional information is received.

• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5404561
• MDR Text Key: 37308202
• Report Number: 3007566237-2016-00516
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 02/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 00014 YR